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Enhanced Medical Rehabilitation for Spinal Cord Injury (EMRSCI Trial)

N/A

Waitlist Available

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

EMRSCI Trial Summary

This trial will test the effects of the Enhanced Medical Rehabilitation program on engagement, intensity, and functional and psychosocial outcomes in patients with spinal cord injuries.

Who is the study for?

This trial is for inpatient therapists with at least six months of experience specializing in spinal cord injury (SCI) patients. They must be willing to undergo EMR training, participate in supervision sessions, collect study measures, and consent to being videotaped during therapy sessions.Check my eligibility

What is being tested?

The trial tests Enhanced Medical Rehabilitation (EMR), a program designed to boost patient engagement and the intensity of therapy for better functional and psychosocial recovery from SCI. It compares EMR's effectiveness against standard care by randomly assigning patients to either approach.See study design

What are the potential side effects?

Since this intervention involves training methods rather than medications or medical procedures, traditional side effects are not applicable. However, there may be risks associated with increased treatment intensity that will be monitored.

EMRSCI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Function: Change in Continuity Assessment Record and Evaluation

Secondary outcome measures

Depression: Change in Patient Health Questionnaire-9

Life Satisfaction: Change in Satisfaction with Life Scale

Other outcome measures

Adherence/Fidelity: Change in Patient Satisfaction & Treatment Fidelity Survey

Adherence/Fidelity: Change in Therapist Adherence Rating Form

Baseline Comorbidity: Charlson Comorbidity Index

+7 more

EMRSCI Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced Medical Rehabilitation (EMR)Experimental Treatment1 Intervention

Patients in the EMR group will also receive the recommended rehabilitation therapy, but they will receive therapy only from four therapists who are trained and supervised in EMR. The therapy sessions will follow EMR protocol. EMR is a set of behavioral skills that therapists can incorporate into their daily therapy sessions to increase patient engagement and achieve a high intensity of therapy, thereby improving functional and psychosocial outcomes of patients in medical rehabilitation.

Group II: Standard of Care (SOC)Active Control1 Intervention

The control group for this study will receive rehabilitation therapy that is recommended and provided by the current healthcare structure. The SOC group will receive therapy only from four therapists who are not trained and supervised in EMR. These therapists will be monitored (videotaped or observed) but will not be not asked to do anything differently with their patients. The investigators recognize that spillover of therapist EMR training to untrained therapists is a concern. Thus, the investigators will ask therapists in the EMR group to agree not to share any of the training with non-trained therapists over the course of the study, and the investigators will provide free EMR training to the non-trained therapists once the treatment phase of the study is complete.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor

192 Previous Clinical Trials

14,805 Total Patients Enrolled

Washington University School of MedicineOTHER

1,931 Previous Clinical Trials

2,299,629 Total Patients Enrolled

Piper Hansen, OTDStudy DirectorShirley Ryan Ability Lab

1 Previous Clinical Trials

80 Total Patients Enrolled

Media Library

Enhanced Medical Rehabilitation (EMR) Clinical Trial Eligibility Overview. Trial Name: NCT05364151 — N/A

Spinal Cord Injury Research Study Groups: Standard of Care (SOC), Enhanced Medical Rehabilitation (EMR)

Spinal Cord Injury Clinical Trial 2023: Enhanced Medical Rehabilitation (EMR) Highlights & Side Effects. Trial Name: NCT05364151 — N/A

Enhanced Medical Rehabilitation (EMR) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05364151 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities remaining for people to participate in this clinical trial?

"Evidentiary data hosted on clinicaltrials.gov illustrates that this particular experimental trial is not presently recruiting patients, despite its initial posting back in May 5th 2022 and update 3 days prior. However, if interested individuals are seeking to participate in a similar study, there are 904 other trials actively taking enrollees right now."

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